1. Field of the Invention
The present invention relates to an oral pharmaceutical dosage form comprising micronized progesterone, an edible oil, a disintegrant, and a hydrophilic excipient.
Particularly, the invention relates to a pharmaceutical dosage form wherein the dosage form is in a powder form and is contained in a pharmaceutically acceptable capsule.
2. Background Art
In the United States, Prometrium® is currently the primary orally administered dosage form of progesterone. Prometrium® capsules are available in either 100 mg or 200 mg capsules. These soft gelatin capsules contain a suspension of progesterone in a fluid consisting primarily of peanut oil. Prometrium® capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogen tablets and for use in treating secondary amenorrhea. However, Prometrium® capsules can have an erratic absorption profile, can have content leakage from the capsule, and are not suitable for patients who are allergic to peanut oil.
Others have tried to produce dosage forms containing progesterone to overcome some of the deficiencies in current products. Tablets, capsules, inhalation powders, oil suspensions, and other dosage forms containing progesterone are disclosed in U.S. Pat. Nos. 4,900,734, 4,963,540, 5,620,705, and 6,001,336. However, these dosage forms do not have the advantages of the present invention.